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FDA Grants Priority Review For Amgen's Supplemental Biologics License Application For BLINCYTO® (Blinatumomab)
Acceptance Reinforces Significant Unmet Need for Difficult-to-Treat Type of Pediatric Acute Lymphoblastic Leukemia
THOUSAND OAKS, Calif., May 3, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome‑negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

"Children and adolescents with ALL who experience a second or greater relapse or are refractory often have a dismal prognosis with survival rates below 10 percent," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The FDA's acceptance of the sBLA submission for BLINCYTO reinforces immunotherapy as a potential option for children in need of new treatments to fight this complex disease and help prevent further relapse."

Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. The Prescription Drug User Fee Act (PDUFA) target action date is Sept. 1, 2016.

ALL is a rare and rapidly progressing cancer of the blood and bone marrow impacting both adults and children and is the most common type of cancer in children.1-3 Of the approximately 2,500 U.S. children and adolescents diagnosed with B-cell precursor ALL each year, approximately 15-20 percent (375-500) will experience relapse or fail to achieve remission.4-7

The sBLA is based on data from the Phase 1/2 '205 single-arm trial, which evaluated BLINCYTO in pediatric patients with relapsed or refractory B-cell precursor ALL. The study met its Phase 2 primary endpoint of complete remission within the first two cycles of BLINCYTO treatment. Overall, the types of serious adverse events (AEs) reported in the pediatric population are consistent with the known BLINCYTO safety profile. The FDA-approved prescribing information for BLINCYTO includes a boxed warning for cytokine release syndrome and neurologic toxicities.
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Source: press release, 5/03/16. http://wwwext.amgen.com/media/news-releases/2016/05/fda-grants-priority-...

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Amgen Submits Supplemental Biologics License Application For BLINCYTO® (Blinatumomab)

Filing Based on Phase 2 Study Showing BLINCYTO Provides Meaningful Therapeutic Benefits in Difficult-to-Treat Type of Pediatric Acute Lymphoblastic Leukemia

THOUSAND OAKS, Calif., March 1, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for BLINCYTO® (blinatumomab) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). BLINCYTO, the first-and-only FDA-approved bispecific CD19-directed CD3 T cell engager (BiTE®) immunotherapy, is currently available under an accelerated approval in the U.S. for the treatment of Ph- relapsed or refractory B-cell precursor ALL, a rare and rapidly progressing cancer of the blood and bone marrow impacting both adults and children.1,2

ALL is the most common type of cancer in children.3 While 95 percent of children with ALL achieve a complete remission with first-line treatment, approximately 650 children in the U.S. each year will relapse or be refractory to treatment.4-6 Pediatric patients with relapsed or refractory ALL have poor long-term outcomes, with an overall survival of less than 10 percent.7 New approaches are needed to improve response rates and help certain patients meet eligibility requirements to receive an allogeneic hematopoietic stem cell transplantation (alloHSCT), the only potentially curative option for patients with relapsed or refractory disease.

"Children with relapsed or refractory ALL have very poor long-term outcomes and currently there are limited available therapies to induce remission," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to collaborating with regulatory authorities to make BLINCYTO available to this ultra-orphan patient population with a high unmet medical need."

The sBLA is based on data from the Phase 1/2 '205 single-arm trial, which found that treatment with BLINCYTO induced complete remission in a clinically meaningful number of pediatric patients with Ph- relapsed or refractory B-cell precursor ALL. Overall, the types of serious adverse events (AEs) reported in the pediatric population are consistent with the known BLINCYTO safety profile. The FDA approved prescribing information for BLINCYTO includes a boxed warning for cytokine release syndrome and neurologic toxicities.
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Source: press release, 3/01/16. http://wwwext.amgen.com/media/news-releases/2016/03/amgen-submits-supple...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Blincyto (Blinatumomab)Oncology HematologicAcute Lymphocytic Leukemia (ALL)Anti-CD19/anti-CD3 bispecific mAbCD19/CD3 antigen

Mechanism of action: Blincyto (Blinatumomab) is a recombinant, single-chain, anti-CD19/anti-CD3 bispecific monoclonal antibody with potential immunostimulating and antineoplastic activities. Blinatumomab posesses two antigen-recognition sites, one for the CD3 complex, a group of T cell surface glycoproteins that complex with the T cell receptor (TCR), and one for CD19, a tumor-associated antigen (TAA) overexpressed on the surface of B cells. This bispecific monoclonal antibody brings CD19-expressing tumor B-cells and cytotoxic T lymphocytes (CTLs) and helper T lymphocytes (HTLs) together, which may result in the CTL- and HTL-mediated cell death of CD19-expressing B-lymphocytes.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-09-01

Results:

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FDA Approves BLINCYTO® (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-cell Precursor Acute Lymphoblastic Leukemia
THOUSAND OAKS, Calif., Sept. 1, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may be contingent upon verification of clinical benefit in subsequent trials.

The approval is based on results from the Phase 1/2 '205, an open-label, multicenter, single-arm trial, which evaluated the efficacy and safety of BLINCYTO in pediatric patients with relapsed or refractory B-cell precursor ALL.
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Source: press release, 9/01/16. http://wwwext.amgen.com/media/news-releases/2016/09/fda-approves-blincyt...

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